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https://www.readbyqxmd.com/read/28447664/efficient-design-of-clinical-trials-and-epidemiological-research-is-it-possible
#1
REVIEW
Michael S Lauer, David Gordon, Gina Wei, Gail Pearson
Randomized clinical trials and large-scale, cohort studies continue to have a critical role in generating evidence in cardiovascular medicine; however, the increasing concern is that ballooning costs threaten the clinical trial enterprise. In this Perspectives article, we discuss the changing landscape of clinical research, and clinical trials in particular, focusing on reasons for the increasing costs and inefficiencies. These reasons include excessively complex design, overly restrictive inclusion and exclusion criteria, burdensome regulations, excessive source-data verification, and concerns about the effect of clinical research conduct on workflow...
April 27, 2017: Nature Reviews. Cardiology
https://www.readbyqxmd.com/read/28443283/vascular-access-site-for-renal-replacement-therapy-in-acute-kidney-injury-a-post-hoc-analysis-of-the-atn-study
#2
Yue-Harn Ng, Kavitha Ganta, Herbert Davis, V Shane Pankratz, Mark Unruh
BACKGROUND: Acute kidney injury requiring renal replacement therapy (RRT) in the intensive care unit portends a poor prognosis. The decisions regarding dialysis catheter placement is based mainly on physician discretion with little evidence to support the choice of dialysis catheter location. METHODS: The Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study was a multicenter, prospective, randomized trial of intensive vs. less intensive RRT in critically ill patients with AKI...
2017: Frontiers in Medicine
https://www.readbyqxmd.com/read/28438584/strategies-for-enhancing-family-participation-in-research-in-the-icu-findings-from-a-qualitative-study
#3
Danae Dotolo, Elizabeth L Nielsen, J Randall Curtis, Ruth A Engelberg
CONTEXT: Family members of critically ill patients who participate in research focused on palliative care issues have been found to be systematically different from those who do not. These differences threaten the validity of research and raise ethical questions about worsening disparities in care by failing to represent diverse perspectives. OBJECTIVES: This study's aims were to explore: 1) barriers and facilitators influencing family members' decisions to participate in palliative care research; and 2) potential methods to enhance research participation...
April 21, 2017: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/28438476/fulfilling-the-psychological-and-information-need-of-the-family-members-of-critically-ill-patients-using-interactive-mobile-technology-a-randomised-controlled-trial
#4
Vico Chung Lim Chiang, Rainbow Lai Ping Lee, Fung Mei Ho, Chi Kwong Leung, Yi Pui Tang, Wing Sze Wong, Yee Sin Ho, Yan Wai Tung, Hang Louie Lai
BACKGROUND: Intensive care nurses may have an important role in empowering families by providing psychological support and fulfilling the family's pivotal need for information. AIM: To determine whether 'education of families by tab' about the patient's condition was more associated with improved anxiety, stress, and depression levels than the 'education of families by routine'. RESEARCH DESIGN: A randomized control trial of 74 main family caregivers (intervention: 39; control: 35)...
April 21, 2017: Intensive & Critical Care Nursing: the Official Journal of the British Association of Critical Care Nurses
https://www.readbyqxmd.com/read/28438182/forced-fluid-removal-versus-usual-care-in-intensive-care-patients-with-high-risk-acute-kidney-injury-and-severe-fluid-overload-ffaki-study-protocol-for-a-randomised-controlled-pilot-trial
#5
Rasmus E Berthelsen, Theis Itenov, Anders Perner, Jens-Ulrik Jensen, Michael Ibsen, Andreas Emil Kryger Jensen, Morten Bestle
BACKGROUND: Intravenous administration of fluids is an essential part of critical care. While some fluid administration is likely beneficial, there is increasing observational evidence that the development of fluid overload is associated with increased mortality. There are no randomised trials to confirm this association in patients with acute kidney injury. We aim to perform a pilot trial to test the feasibility of forced fluid removal compared to standard care in patients with acute kidney injury and severe fluid overload, the FFAKI trial...
April 24, 2017: Trials
https://www.readbyqxmd.com/read/28437539/safety-and-efficacy-of-antiviral-therapy-for-prevention-of-cytomegalovirus-reactivation-in-immunocompetent-critically-ill-patients-a-randomized-clinical-trial
#6
Nicholas J Cowley, Andrew Owen, Sarah C Shiels, Joanne Millar, Rebecca Woolley, Natalie Ives, Husam Osman, Paul Moss, Julian F Bion
Importance: Latent cytomegalovirus (CMV) infection is present in more than half the adult population, and a viral reactivation (ie, when the virus becomes measurable in body fluids such as blood) can occur in up to one-third of these individuals during episodes of critical illness. Objective: To determine whether antiviral therapy is safe and effective for preventing CMV reactivation in a general population of critically ill patients. Design, Setting, and Participants: A single-center, open-label, randomized, controlled clinical trial recruited 124 CMV-seropositive patients undergoing mechanical ventilation for at least 24 hours in the intensive care unit between January 1, 2012, and January 31, 2014...
April 24, 2017: JAMA Internal Medicine
https://www.readbyqxmd.com/read/28436107/a-complete-4dct-ventilation-functional-avoidance-virtual-trial-developing-strategies-for-prospective-clinical-trials
#7
Timothy Waxweiler, Leah Schubert, Quentin Diot, Austin Faught, Kelly Stuhr, Richard Castillo, Edward Castillo, Thomas Guerrero, Chad Rusthoven, Laurie Gaspar, Brian Kavanagh, Moyed Miften, Yevgeniy Vinogradskiy
INTRODUCTION: 4DCT-ventilation is an exciting new imaging modality that uses 4DCT data to calculate lung-function maps. Because 4DCTs are acquired as standard of care for lung cancer patients undergoing radiotherapy, 4DCT-ventiltation provides functional information at no extra dosimetric or monetary cost to the patient. The development of clinical trials is underway to use 4DCT-ventilation imaging to spare functional lung in patients undergoing radiotherapy. The purpose of this work was to perform a virtual trial using retrospective data to develop the practical aspects of a 4DCT-ventilation functional avoidance clinical trial...
April 24, 2017: Journal of Applied Clinical Medical Physics
https://www.readbyqxmd.com/read/28431428/computational-and-in-vitro-experimental-investigation-of-intrathecal-drug-distribution-parametric-study-of-the-effect-of-injection-volume-cerebrospinal-fluid-pulsatility-and-drug-uptake
#8
Kevin M Tangen, Roxanne Leval, Ankit I Mehta, Andreas A Linninger
BACKGROUND: Intrathecal drug delivery is an attractive option to circumvent the blood-brain barrier for pain management through its increased efficacy of pain relief, reduction in adverse side effects, and cost-effectiveness. Unfortunately, there are limited guidelines for physicians to choose infusion or drug pump settings to administer therapeutic doses to specific regions of the spine or the brain. Although empiric trialing of intrathecal drugs is critical to determine the sustained side effects, currently there is no inexpensive in vitro method to guide the selection of spinal drug delivery parameters...
May 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28428892/a-comparison-of-earlier-and-enhanced-rehabilitation-of-mechanically-ventilated-patients-in-critical-care-compared-to-standard-care-rehab-study-protocol-for-a-single-site-randomised-controlled-feasibility-trial
#9
Catherine Snelson, Charlotte Jones, Gemma Atkins, James Hodson, Tony Whitehouse, Tonny Veenith, David Thickett, Emma Reeves, Aisling McLaughlin, Lauren Cooper, David McWilliams
BACKGROUND: Mortality from critical illness is improving, but survivors suffer from prolonged weakness and psychological and cognitive impairments. Maximising the recovery after critical illness has been highlighted as a research priority, especially in relation to an ageing population who present with higher rates of pre-morbid disability. Small studies have shown that starting rehabilitation early within the intensive care unit (ICU) improves short-term outcomes. Systematic reviews have highlighted the need for robust multicentre randomised controlled trials with longer term follow-up...
2017: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/28428813/perinatal-depression-in-nigeria-perspectives-of-women-family-caregivers-and-health-care-providers
#10
Ademola Adeponle, Danielle Groleau, Lola Kola, Laurence J Kirmayer, Oye Gureje
BACKGROUND: Perinatal maternal depression is common and undertreated in many sub-Saharan African countries, including Nigeria. While culture shapes the social determinants and expression of depressive symptoms, there is a dearth of research investigating these processes in African contexts. METHODS: To address this gap, we conducted in-depth interviews with 14 women with perinatal depression, 14 of their family caregivers and 11 health providers, using the McGill Illness Narrative Interview as part of a larger trial of a stepped-care intervention...
2017: International Journal of Mental Health Systems
https://www.readbyqxmd.com/read/28427372/protocol-for-evaluation-of-the-continuum-of-primary-care-in-the-case-of-a-miscarriage-in-the-emergency-room-a-mixed-method-study
#11
Francine de Montigny, Chantal Verdon, Diane Dubeau, Annie Devault, Martin St-André, Éric Tchouaket Nguemeleu, Carl Lacharité
BACKGROUND: In Quebec (Canada), nearly 20,000 pregnancies end in miscarriage, and the majority of the miscarriages are dealt with in an emergency unit. Although there are studies documenting the effects of this type of grief on mental health, men's experiences are much less discussed than those of women. Similarly, no study has evaluated best practices in terms of service continuity, from emergency care to community resources. The aim of this study is to better understand the relationships that exist between the organization of emergency room and primary care health services for women presenting with miscarriage, on the one hand, and the positions and experiences of women and men within these services, on the other...
April 20, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28427076/application-of-clinical-trial-results-to-clinical-practice
#12
Marco A Zarbin, Neelakshi Bhagat, Lekha K Mukkamala
Two critical questions one must answer as one applies the results of a clinical trial to clinical practice are: (1) Regardless of whether the trial result is likely to be replicated or reproduced in a second large-scale trial, are the results likely to be reproduced in one's practice? (2) Regardless of whether the experimental treatment was better than the alternative on average for a population of patients, are the results clinically important for a given patient in one's practice? To determine if a study result is likely to be reproduced in one's clinical practice, it may be helpful to answer 5 questions: (1) Have steps been taken to minimize bias? (2) Is the result likely due to the treatment? (3) Is the result unlikely due to chance? (4) Is the study population representative of one's patients? (5) Is the totality of evidence consistent? If the answer to all 5 questions is "yes," then we posit that the trial result is likely to be reproduced in one's practice...
2017: Developments in Ophthalmology
https://www.readbyqxmd.com/read/28422779/the-utility-of-high-fidelity-simulation-for-training-critical-care-fellows-in-the-management-of-extracorporeal-membrane-oxygenation-emergencies-a-randomized-controlled-trial
#13
Bishoy M Zakhary, Lily M Kam, Brian S Kaufman, Kevin J Felner
OBJECTIVE: Although extracorporeal membrane oxygenation volume has increased, proficiency in the technology requires extensive training. We compared traditional water-drill-based extracorporeal membrane oxygenation training with simulation-based extracorporeal membrane oxygenation training with the hypothesis that simulation-based training is superior. DESIGN: Randomized controlled trial. SETTING: Academic medical center. SUBJECTS: Pulmonary/critical care fellows...
April 18, 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28422777/population-based-epidemiology-of-sepsis-in-a-subdistrict-of-beijing
#14
Jianfang Zhou, Hongcheng Tian, Xueping Du, Xiuming Xi, Youzhong An, Meili Duan, Li Weng, Bin Du
OBJECTIVE: Information about the epidemiology of sepsis in community residents in China remains scarce and incomplete. The purpose of this study was to describe the occurrence rate and outcome of sepsis in Yuetan Subdistrict of Beijing and to estimate the occurrence rate of sepsis in China. DESIGN: Retrospective cohort study. SETTING: All public hospitals serving residents in Yuetan Subdistrict, Beijing. PATIENTS: All patients (n = 1,716) meeting criteria for sepsis based on American College of Chest Physicians/Society of Critical Care Medicine consensus definition...
April 18, 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28416497/prognostication-in-critically-ill-patients-with-severe-traumatic-brain-injury-the-tbi-prognosis-multicentre-feasibility-study
#15
Alexis F Turgeon, François Lauzier, Ryan Zarychanski, Dean A Fergusson, Caroline Léger, Lauralyn A McIntyre, Francis Bernard, Andrea Rigamonti, Karen Burns, Donald E Griesdale, Robert Green, Damon C Scales, Maureen O Meade, Martin Savard, Michèle Shemilt, Jérôme Paquet, Jean-Luc Gariépy, André Lavoie, Kesh Reddy, Draga Jichici, Giuseppe Pagliarello, David Zygun, Lynne Moore
OBJECTIVE: Severe traumatic brain injury is a significant cause of morbidity and mortality in young adults. Assessing long-term neurological outcome after such injury is difficult and often characterised by uncertainty. The objective of this feasibility study was to establish the feasibility of conducting a large, multicentre prospective study to develop a prognostic model of long-term neurological outcome in critically ill patients with severe traumatic brain injury. DESIGN: A prospective cohort study...
April 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28416020/patient-and-family-centered-performance-measures-focused-on-actionable-processes-of-care-for-persistent-and-chronic-critical-illness-protocol-for-a-systematic-review
#16
Louise Rose, Laura Istanboulian, Laura Allum, Lisa Burry, Craig Dale, Nicholas Hart, Claire Kydonaki, Pam Ramsay, Natalie Pattison, Bronwen Connolly
BACKGROUND: Approximately 5 to 10% of critically ill patients transition from acute critical illness to a state of persistent and in some cases chronic critical illness. These patients have unique and complex needs that require a change in the clinical management plan and overall goals of care to a focus on rehabilitation, symptom relief, discharge planning, and in some cases, end-of-life care. However, existing indicators and measures of care quality, and tools such as checklists, that foster implementation of best practices, may not be sufficiently inclusive in terms of actionable processes of care relevant to these patients...
April 17, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28413520/prognosis-of-patients-with-acinetobacter-baumannii-infection-in-the-intensive-care-unit-a-retrospective-analysis
#17
Dong Xiao, Lu Wang, Daquan Zhang, Dongming Xiang, Qi Liu, Xuezhong Xing
The present retrospective study aimed to investigate the prognostic factors for critically ill patients with an Acinetobacter baumannii (A. baumannii) infection. A total of 37 patients from the intensive care unit (ICU) were enrolled in the study. Data was collected from patients, including age, gender, ethnicity, A. baumannii infection status, concurrent infection status, prescribed antibiotics, Acute Physiology and Chronic Health Evaluation II (APACHE II) and sepsis-related organ failure assessment (SOFA) scores, procalcitonin level, site of infection, shock, sepsis and renal replacement therapy status...
April 2017: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/28411508/interventions-to-support-people-with-dementia-and-their-caregivers-during-the-transition-from-home-care-to-nursing-home-care-a-systematic-review
#18
REVIEW
Christian Müller, Sindy Lautenschläger, Gabriele Meyer, Astrid Stephan
BACKGROUND: During the transition of people with dementia from home to nursing home family caregivers often feel burdened. OBJECTIVES: We aimed to 1) identify interventions which support people with dementia and their caregivers in the transition from home care to nursing home care, 2) synthesize the evidence for efficacy of these interventions, and 3) examine whether the identified interventions have been systematically developed, evaluated and implemented according to the Medical Research Council guidance on complex interventions...
April 3, 2017: International Journal of Nursing Studies
https://www.readbyqxmd.com/read/28411422/ventilation-distribution-and-lung-recruitment-with-speaking-valve-use-in-tracheostomised-patient-weaning-from-mechanical-ventilation-in-intensive-care
#19
Anna-Liisa Sutt, Chris M Anstey, Lawrence R Caruana, Petrea L Cornwell, John F Fraser
PURPOSE: Speaking valves (SV) are used infrequently in tracheostomised ICU patients due to concerns regarding their putative effect on lung recruitment. A recent study in cardio-thoracic population demonstrated increased end-expiratory lung volumes during and post SV use without examining if the increase in end-expiratory lung impedance (EELI) resulted in alveolar recruitment or potential hyperinflation in discrete loci. MATERIALS AND METHODS: A secondary analysis of Electrical Impedance Tomography (EIT) data from a previous study was conducted...
April 8, 2017: Journal of Critical Care
https://www.readbyqxmd.com/read/28410087/racial-and-ethnic-disparities-in-parental-refusal-of-consent-in-a-large-multisite-pediatric-critical-care-clinical-trial
#20
Joanne E Natale, Ruth Lebet, Jill G Joseph, Christine Ulysse, Judith Ascenzi, David Wypij, Martha A Q Curley
OBJECTIVE: To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. STUDY DESIGN: We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation...
May 2017: Journal of Pediatrics
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